Prednisolone Sodium Phosphate

Product NDC
67296-1505
11-digit product format
672961505
Labeler code
67296
Product ID
67296-1505_d61fb856-cf54-4500-e053-2995a90ad417
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA076913
Marketing category
ANDA
Marketing start
2005-04-25
Marketing end
0000-00-00
Substance
PREDNISOLONE SODIUM PHOSPHATE
Active strength
15 mg/5mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1505IInactivated by FDA2026-08-17
excluded packagepackage67296-150567296-1505-6IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1505-6IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1505-6IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1505-6IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1505-6IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67296-1505-6EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076913-001PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076913-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-253f01610625f2…
2019-09-15 20:21 UTC2019-09A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAARS2005-04-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076913-001PREDNISOLONE SODIUM PHOSPHATEEQ 15MG BASE/5MLSOLUTION / ORALAA2005-04-25e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076913-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076913-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076913-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076913-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076913-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076913-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076913-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076913-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076913-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076913-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076913-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076913-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076913-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076913-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076913-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076913-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076913-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076913-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076913-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076913-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076913-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076913-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A076913-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076913-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076913-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076913-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A076913-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076913-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076913-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076913-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076913-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076913-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076913-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076913-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076913-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076913-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076913-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076913-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076913-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076913-001AA1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3fecff3-fb51-4f66-b443-a130905bb500Product name120250804
3a7a0034-a88d-88c3-f43e-ea34c6a216deProduct name220250311
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
9dbc4744-f7be-4393-b71a-e1bfd8b97659Product name220250218
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5Product name220240102
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553aProduct name120170309
af7d3306-1338-423f-839e-419aad9e8a86Product name120170309
18d57d04-4a34-a130-5dd5-b7fc47f3b567Product name120140508
379bc253-901a-e6e1-92b7-0fc574249e07Product name120140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890dProduct name120140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
9f10552a-9a7b-8e6c-3223-dc44310af6cfProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1505-6Prednisolone Sodium Phosphate60 mL in 1 BOTTLESOLUTION607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1505PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REDPHARM DRUG, INC.]7Legacy NDC, 1 package rows20240809_50d651cc-e417-3b40-e054-00144ff8d46c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPreferred Pharmaceuticals, Inc.93b372f7-b811-4c15-85c4-c6dbac342cb42026-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076913
application number: ANDA076913
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEREMEDYREPACK INC.f87ce1ba-335e-463d-87d5-9af0206f8f612026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076913
application number: ANDA076913
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEPAI Holdings, LLC dba PAI Pharmaa0d74ae0-7b2d-4d36-9211-c76f5063b5a92025-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076913
application number: ANDA076913
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEA-S Medication Solutions4c507319-8add-4952-8bea-ff77ab17088f2025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076913
application number: ANDA076913
Prednisolone Sodium PhosphatePREDNISOLONE SODIUM PHOSPHATEProficient Rx LP14b7f41b-4df1-42cb-bd1b-c74b28de26702021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076913
application number: ANDA076913

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283077prednisoLONE sodium phosphate 15 MG in 5 mL Oral SolutionPSN50d651cc-e417-3b40-e054-00144ff8d46c7
283077prednisolone 3 MG/ML Oral SolutionSCD50d651cc-e417-3b40-e054-00144ff8d46c7
283077prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral SolutionSY50d651cc-e417-3b40-e054-00144ff8d46c7
283077prednisolone 15 MG per 5 ML Oral SolutionSY50d651cc-e417-3b40-e054-00144ff8d46c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1505-66729615050660 mL in 1 BOTTLE (67296-1505-6) 60 ml2005-04-250000-00-00NoNoCurrent